Actively Recruiting
Effects of Red and Infrared Photobiomodulation in Rhinoplasty at a Single Centre
Led by University of Nove de Julho · Updated on 2026-03-24
60
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This single-centre, randomized, double-blind, sham-controlled clinical trial evaluates whether preoperative photobiomodulation (PBM) with red and infrared light can reduce early postoperative periorbital edema in patients undergoing primary open rhinoplasty with osteotomies. Sixty participants will be randomly assigned to receive active PBM or sham PBM one hour before surgery. The primary outcome is periorbital edema on postoperative day 3 measured using a validated ordinal clinical scale with standardized photographic documentation. Secondary outcomes include ecchymosis, postoperative pain, analgesic consumption, nasal tip skin thickness, and patient-reported functional and aesthetic outcomes. Participants will be followed for up to 12 months after surgery.
CONDITIONS
Official Title
Effects of Red and Infrared Photobiomodulation in Rhinoplasty at a Single Centre
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals 18 to 60 years old
- ASA physical status I or II with no pre-existing diseases
- Indicated for rhinoplasty surgery
- Any gender identity
You will not qualify if you...
- Current use of anticoagulant, anti-inflammatory, or corticosteroid medications
- Indication for closed rhinoplasty
- Procedures not performed using the Piezo device (Schuster SW Surgery II)
- Intraoperative complications such as hemorrhage or technical difficulties
- Prior nasal filler with hyaluronic acid
- Use of vitamin A derivatives (oral isotretinoin or topical retinoic acid) within 30 days before surgery
- Known allergy to any required intra- or postoperative medication
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital Paulista de Otorrinolaringologia
São Paulo, São Paulo, Brazil, 02404001
Actively Recruiting
Research Team
C
Cinthya CG Duran, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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